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Drug manufacturers are not insurers against injury from or while taking medications.  Neither are distributors or pharmacies.  Just because a patient experiences a complication while taking a medication, including the very condition the medication is supposed to help prevent, does not mean that some person or entity should be liable to the patient for her injuries.  Sometimes, there is no fault or liability to be found.  We do not think these are controversial principles, but we find that they apply to more than a few of the cases giving rise to the decisions about which we expound.

We also find that missing facts from complaints can speak volumes.  Similarly, when a plaintiff waits until the third complaint to add case-specific factual allegations that should have been there from the start or when factual allegations pop in and out of serial amendments you have to question the basis for those allegations.  At least we do.  As inveterate curmudgeons, we tend to think bare-bones, boilerplate allegations are unlikely to be supported if the case gets to the merits.  Of course, part of the game for some plaintiffs is to get past pleadings and hope the defendants opt for settlement instead of paying the costs of defense.  The Twombly and Iqbal decisions tightened pleading standards, and thus improved the chance of success on motions to dismiss in federal court and some states have followed along.  The hole, and source of our periodic grumbling, is how often dismissals are without prejudice and accompanied by leave to amend.  Too often, it seems that the provision in Fed. R. Civ. P. 15 that courts “should freely give leave when justice so requires” leads to leave even when it should be obvious that amendment will be futile, not to mention a waste of judicial resources.

With that predicate, we turn to Meinhart v. Hy-Vee, Inc., 2002 IL App. (2d) 220042-U (Ill. App.. Ct. 2d 2022), in which a dismissal with prejudice on the fifth version of plaintiff’s complaint got her to an appeal, where she promptly waived two of her four grounds for appeal.  Plaintiff’s fundamental claim, boiled down from shifting allegations, was that she had seizures after shifting from one generic version of a prescription anti-epileptic medication to another.  Her blood levels of the medication were found to be below the therapeutic range, so she alleged the new generic must have been weaker than it was supposed to be and that this deviation must have caused her seizures to return.  We say return because the plaintiff was epileptic, had prior seizures on this same medication previously (apparently before her regimen was adjusted), and was also taking a second prescription anti-epileptic medication.  Failure of a prescription medication to prevent some manifestation of the underlying medical condition for which it was prescribed is generally not actionable under any legal theory.  The labeled indications for the medication primarily at issue in Meinhart are the “adjunctive therapy in the treatment” of various types of seizures in specific epileptic populations; there is nothing in the label coming close to a promise that the ingestion of the prescribed medication will prevent all seizures in all patients for all times.

Yet, plaintiff combined the post hoc ergo propter hoc fallacy with a range of legal theories offered against the pharmacy and generic drug manufacturer, as well as the pharmacist and pharmacy technician, although they were never served.  Plaintiff focused heavily on how the color of the pills she was taking when her seizures returned—filled more than a month before but started close to when the seizures began—were pink and the ones she had been taking for several years before were yellow.  They were both supposed to be 500 mg.  Curiously, plaintiff never offered any allegations as to what brand she had been taking or that testing of the new generic medication showed that did, in fact, contain less active substance than it was supposed to.  We spent a few minutes on some government websites—as the plaintiff lawyer might have when drafting one or more of the five complaints—and saw that 1) the 500 mg tablet from the branded manufacturer has been out since 1999 and is yellow, 2) a number of different generic versions came out starting in 2008 and the color of their 500 mg tablets varied, and 3) the 250, 500, and 750 mg tablets from the manufacturer defendant were each pink but bore a different “debossed” number on each.  It should have been pretty easy to see if the tablets at issue had the right number (22) on them and if they contained the right amount of active ingredient.  If, in the days leading up to the return of her seizures, the plaintiff had not been taking three tablets per day as directed by her physician and that was the reason for her low blood levels, however, then perhaps it would have been hard for plaintiff to admit that and still push her lawsuit.  But push she did.

We will not go through all the ins and outs of each complaint and their conflicting factual allegations.  The first complaint offered negligence and strict liability claims against the pharmacy, claiming that the pharmacy voluntarily undertook a duty to warn based on the pharmacist responding with “o.k.” when asked if the plaintiff could take pills of a different color.  2002 IL App. (2d) 220042-U, *2.  After all the claims in the initial complaint and a first amended complaint had been dismissed, plaintiff received leave to try to replead her strict liability claims, which had been dismissed without prejudice.  Id. at *4.  Plaintiff filed a “third [sic] amended complaint” that featured a new count for “res ipsa loquitar [sic]” and the defendant pharmacy again moved to dismiss.  Id.  As what should have been plaintiff’s third strike was heading to the outside corner of the proverbial plate, plaintiff was granted leave to add the manufacturer of pink generic drug as a defendant.  We do not think that should have happened—among other things, the manufacturer’s identify was known or easily knowable from the start—especially with the pharmacy still a defendant and subject to shifting claims and theories.  The “fourth [sic] amended complaint” included strict liability claims against the manufacturer, which moved to dismiss principally on preemption, citing the approval of its ANDA for 500 mg and other dosage tablets.  Id. at *4-5.  The purported res ipsa claims against both defendants were dismissed with prejudice, but the strict liability claims were dismissed without prejudice.  Again, we think it should have been clear at this point that amendment, including trying to plead a non-preempted claim against the manufacturer, would be futile.  Plaintiff was permitted to try one more time with her “fifth [sic] amended complaint” and all remaining claims were finally dismissed with prejudice after another round of briefing an argument.  Id. at *6-7.  (Maybe Illinois has unlimited judicial resources and/or its rule that “amendments may be allowed on just and reasonable terms” is even more pro-amendment than Fed. R. Civ. P. 15.)

On appeal, two of the issues that had featured prominently in the history below were “forfeited” by plaintiff’s failure to offer a serious and supported argument on them.  The first was whether a pharmacy could have duty to warn for purposes of strict liability given the adoption of the learned intermediary doctrine in Illinois.  The second was whether a strict liability manufacturing defect claim had been asserted, which would have involved a look at the quirky Tweedy doctrine, discussed here.  Despite these forfeitures, the court proceeded to assess whether the strict liability claims against the generic manufacturer would have been preempted.  We would normally dig in on the preemption analysis, but plaintiff again forfeited the argument that might have made the analysis more interesting:  that the tablets dispensed to plaintiff were “adulterated” as that term is used in the FDCA and that the manufacturer failed to warn of the adulteration, making the drug “misbranded” as that term is used in the FDCA.  Without that argument, this was straightforward preemption under the double whammy of Bartlett and MensingId. at *12-14.

Working backwards, the court considered the dismissal of the negligence claim against the pharmacy and the purported res ipsa claims against both defendants.  The former turned on the argument that, despite the learned intermediary doctrine meaning the pharmacy generally did not have a duty to warn the plaintiff of the risks of the drugs she was prescribed, the pharmacy somehow created and breached a duty through the pharmacist’s response to a question about the change in the color of the dispensed pills.  Illinois follows section 323 of the Restatement (Second) of Torts, so it does recognize a claim for negligence based on a voluntary undertaking, but “[a]s the trial court reasoned, [the pharmacy] did not undertake to do anything more than substitute generic for generic.”  Id. at *9.  Without a duty, there could be no breach.

As to the latter, we have made no secret that most attempts by plaintiffs in drug and device product liability cases are bunk.  (Like here , here, and here.)  It should not be a surprise that the plaintiff who misspelled “loquitur” when she tried to assert a new claim in her third complaint did not grasp that res ipsa loquitur is not a recognized cause of action.  The Meinhart court did:

Importantly, res ipsa loquitur is not a claim in of itself; rather, it is an evidentiary doctrine that allows a plaintiff to prove negligence under a unique set of proofs.  That is, satisfaction of the res ipsa loquitur elements is not sufficient to establish a cause of action for negligence.

Id. at *10 (internal quotation and citation omitted).  Plaintiff never got past the duty element of negligence.  As above, she failed to allege a legally recognized duty by the pharmacy.  She did not even try as to the manufacturer.

So, was this all a bunch of sound and fury, signifying nothing?  While we cannot say that MacBeth’s preceding clause applies, the answer is “pretty much.”  The lesson we hope judges take is not to allow serial amendment of futile claims.  We do not hold out hope that any potential plaintiffs will take the obvious lesson here for them